Job Information
BeiGene Manager, CGP Compliance in San Mateo, California
General Description:
This position will report directly to the Director, GCP Compliance within the Clinical Operations Americas group. This individual will be integral to GCP inspection readiness efforts at BeiGene and will serve as a GCP compliance expert to the organization. Additionally, Manager, GCP Compliance will assist with proactive and continuous process improvement, including the development and revision of Standard Operating Procedures, Work Instructions & Templates as well as assisting with the effective resolution of deviations, audit and regulatory inspection findings. This position requires the candidate to:
Have excellent working knowledge of ICH/GCP, local regulations, SOPs and Clinical Operations Work Instructions
Demonstrate a high level of clinical operations knowledge, organizational skills, presentation skills and training skills
Ensure appropriate escalation of quality issues, potential misconduct and significant deviations to relevant stakeholders
Responsibilities - may include, but not be limited to :
Leads or supports the development of a GCP inspection readiness program at a local and/or global level, including creation of tools to be utilized
Conducts or assists in gap analysis to identify potential compliance risks.
Provides GCP and compliance guidance to Clinical Operations personnel.
Collaborates with Medical & Clinical Quality group to complete investigations, root-cause analysis and action items related to CAPAs.
Track GCP audits of vendors, sites and TMF and ensure findings are fed back into the GCP inspection readiness program or appropriate training or processes.
Proposes, develops or supports the development and implementation of internal GCP compliance process improvement strategies, tools, initiatives or workstreams.
Tracks KPIs and prepares reports to be presented to senior management.
Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
Occasionally, develops and/or delivers GCP and compliance training
Liaises with co-monitors and global/regional leads to provide input into quality oversight visit planning
Contribute to GCP Council
May provide input to key clinical documents, including but not limited to protocols, investigator brochures, informed consent forms and clinical study reports
Supervisory Responsibilities:
Mentors more junior study team members by delegating responsibilities, overseeing and providing support with assigned tasks, in line with their development plans
May line manage junior roles
Education Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline or equivalent experience.
General Requirements:
Minimum of 5 years progressive experience in clinical operations, preferably within the biotech/ pharmaceutical sector
GCP experience is a must
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.